The following data is part of a premarket notification filed by Metronic, Inc. with the FDA for Model 5866-9m & Model 6981m.
| Device ID | K911827 |
| 510k Number | K911827 |
| Device Name: | MODEL 5866-9M & MODEL 6981M |
| Classification | Pacemaker Lead Adaptor |
| Applicant | METRONIC, INC. 7000 CENTRAL AVENUE, N.E. Minneapolis, MN 55432 |
| Contact | Tracy A Malm |
| Correspondent | Tracy A Malm METRONIC, INC. 7000 CENTRAL AVENUE, N.E. Minneapolis, MN 55432 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-24 |
| Decision Date | 1991-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994897947 | K911827 | 000 |
| 00681490153553 | K911827 | 000 |